Budesonide

ANDA 201966, held by Sandoz. Budesonide.

As of Nov 15, 2026, ANDA 201966 (Budesonide), held by Sandoz, was first approved by FDA on Sep 27, 2013, with 1 approved supplement and 0 published complete response letters.

First approved: Sep 27, 2013
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Sep 27, 2013	Original application	Approved	None posted

Products

3 strengths and forms


Budesonide1MG/2ML · suspension;inhalation	Budesonide	Discontinued
Budesonide0.5MG/2ML · suspension;inhalation	Budesonide	Discontinued
Budesonide0.25MG/2ML · suspension;inhalation	Budesonide	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Mar 31, 2021	Supplement 9Labeling · Standard review	Approved	None posted
Sep 27, 2013	Original application	Approved	None posted

Identifiers

Application: ANDA 201966
Drugs@FDA: Overview at FDA
Company: Sandoz

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters